Study of AS1411 in Advanced Solid Tumours

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-09-30

Study Completion Date

2007-02-28

Brief Summary

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A Phase I open label study of AS1411 in advanced solid tumours. Objectives include determining the MTD and DLT of AS1411, to determine the PK profile of AS1411 and to obtain preliminary evidence of clinical and biological responses to AS1411 therapy.

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Detailed Description

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Conditions

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Advanced Solid Tumors

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

AS1411

Group Type EXPERIMENTAL

AS1411

Intervention Type DRUG

I.v. 4-7 days, 1-40 mg/kg/day

Interventions

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AS1411

I.v. 4-7 days, 1-40 mg/kg/day

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients with advanced solid tumours that were refractory to conventional/standard treatment
* Age \>/ 18 years
* ECOG performance status \</ 2 (Karnofsky \>/60%
* Life expectancy \>/ 8 weeks
* Adequate organ and marrow function

Exclusion Criteria

* Radiotherapy or chemotherapy in the 4 weeks before study entry (6 weeks for nitrosourea or mitomycin C
* Lack of recovery from adverse events (AEs) caused by agents administered before study entry; current use of other investigational agent(s)
* Uncontrolled brain metastases including a need for corticosteroid therapy
* Pregnancy
* Uncontrolled intercurrent illness
* Psychiatric illness/social situations that could limit compliance

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No